HealingProSURGNCT07200518
Effect of Probiotics After Neurosurgery
A study testing OMNi-BiOTiC® Hetox multistrain probiotic in people with Healing, run by University Maribor at 1 site in Slovenia.
Trial summary
The goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic OMNi-BiOTiC® Hetox on improving the healing, pain management, and postsurgical complications after neurosurgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healing
- What is being tested?
- OMNi-BiOTiC® Hetox multistrain probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 Nov 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults with MRI-confirmed disc herniation, stenosis, or instability of the lumbar or cervical spine.
- Able to provide written informed consent
- Willing to comply with study procedures and follow-up assessments
- No contraindications to probiotic administration
Who cannot join
- symptoms of acute infection (vomiting, fever above 38°C, diarrhea, respiratory symptoms),
- chronic diseases,
- use of probiotics one month before inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Maribor
Maribor
Tomaž Šmigoc, dr.med., +3862 321 1000, tomaz.smigoc@ukc-mb.si
About this study
Official title: The Multistrain Probiotic OMNi-BiOTiC® Hetox for Treatment After Neurosurgery (ProSURG)
The goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic OMNi-BiOTiC® Hetox on improving the healing, pain management, and postsurgical complications after neurosurgery.
The main question it aims to answer is:
- Is the multistrain probiotic OMNi-BiOTiC® Hetox effective in in improving patient-reported disability after neurosurgery?
Researchers will compare the probiotic group and the placebo group to determine if the healing is significantly different between the groups.
- Conditions
- Healing
- Being tested
- OMNi-BiOTiC® Hetox multistrain probiotic, Placebo
- Keywords
- neurosurgery, probiotics, Omni-Biotic Hetox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNi-BiOTiC® Hetox multistrain probioticDietary supplement
OMNi-BiOTiC® Hetox multistrain probiotic
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Lacticaseibacillus casei W56 Lactobacillus acidophilus W37 Levilactobacillus brevis W63 Lactococcus lactis W58 Lactococcus lactis W19 Bifidobacterium lactis W52 Ligiactobacillus salivarius W24 Bifidobacterium lactis W51 Bifidobacterium bifidum W23 corn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, amylase manganese sulphate Receives: Dietary Supplement: OMNi-BiOTiC® Hetox multistrain probiotic |
| Placebo | Placebo comparator | corn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, amylase manganese sulphate Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Oswestry Disability Index (ODI) at 3 months
Functional disability will be assessed using the Oswestry Disability Index (ODI, version 2.1a; range 0-100, higher = greater disability). The primary outcome is the mean change in ODI from baseline to 3 months post-neurosurgery.
Measured: 4 weeks supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start3 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Maribor
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Maribor
- Responsible party
- Principal investigator, Sabina Fijan, University Maribor
- Investigators
- TOMAŽ ŠMIGOC, dr. med., Study director, University Medical Centre MariborSabina Fijan, Ph.D., Study director, University of Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200518
- Sponsor's protocol ID
- UKC-MB-KME-38/24
- Acronym
- ProSURG
- Status last verified
- Nov 2025
- First submitted
- 18 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multistrain Probiotic OMNi-BiOTiC® Hetox for Treatment After Neurosurgery (ProSURG)
- ClinicalTrials.gov ID
- NCT07200518
- Acronym / sponsor ID
- ProSURG / UKC-MB-KME-38/24
- Conditions
- Healing
- Keywords
- neurosurgery, probiotics, Omni-Biotic Hetox
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University MariborUniversity, hospital or other
- Collaborators
- University Medical Centre Maribor
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic OMNi-BiOTiC® Hetox on improving the healing, pain management, and postsurgical complications after neurosurgery.
The main question it aims to answer is:
- Is the multistrain probiotic OMNi-BiOTiC® Hetox effective in in improving patient-reported disability after neurosurgery?
Researchers will compare the probiotic group and the placebo group to determine if the healing is significantly different between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: OMNi-BiOTiC® Hetox multistrain probioticLacticaseibacillus casei W56 Lactobacillus acidophilus W37 Levilactobacillus brevis W63 Lactococcus lactis W58 Lactococcus lactis W19 Bifidobacterium lactis W52 Ligiactobacillus salivarius W24 Bifidobacterium lactis W51 Bifidobacterium bifidum W23 corn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, amylase manganese sulphate |
| Placebo | Placebo comparator | Dietary Supplement: Placebocorn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, amylase manganese sulphate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults with MRI-confirmed disc herniation, stenosis, or instability of the lumbar or cervical spine.
- Able to provide written informed consent
- Willing to comply with study procedures and follow-up assessments
- No contraindications to probiotic administration
Key exclusion criteria (3 listed)
- symptoms of acute infection (vomiting, fever above 38°C, diarrhea, respiratory symptoms),
- chronic diseases,
- use of probiotics one month before inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNi-BiOTiC® Hetox multistrain probioticOMNi-BiOTiC® Hetox multistrain probiotic | Dietary supplement | Probiotic |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Change from baseline in Oswestry Disability Index (ODI) at 3 months
Time frame: 4 weeks supplementation
Functional disability will be assessed using the Oswestry Disability Index (ODI, version 2.1a; range 0-100, higher = greater disability). The primary outcome is the mean change in ODI from baseline to 3 months post-neurosurgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
TOMAŽ ŠMIGOC, dr. med. study director
University Medical Centre Maribor
Sabina Fijan, Ph.D. study director
University of Maribor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNi-BiOTiC® Hetox multistrain probiotic in people with Healing, run by University Maribor at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SABINA FIJAN, Ph.D. (+38623004755, sabina.fijan@um.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Oswestry Disability Index (ODI) at 3 months (time frame: 4 weeks supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.